Blood Pressure Unit — Class II medical device recall Z-1459-2024
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-04-10, distributed nationwide. The firm provided a set of specifications for the device, but some units of the device were manufactured non-c
| Recall number | Z-1459-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2024-02-26 |
| Classified | 2024-04-01 |
| Reported by FDA | 2024-04-10 |
| Distributed | Nationwide (US) |
| Quantity | 74,339 units |
| Lot numbers | 230280001, 230280004, 230380001, 230480003, 230480004, 230680001, 230780001, 230780003, 230780004, 230880001, 231080004, 231180003 |
| Model numbers | MDS4001, MDS4001LA, MDS4001PLUS |
Product
Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS
Reason for recall
The firm provided a set of specifications for the device, but some units of the device were manufactured non-compliant with the specifications. However, the firms Receiving Dept. accepted these units into inventory
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1459-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.